The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Lumipulse G1200 System, Lumipulse G Ca 125ii Immunoreaction Cartridges, Lumipulse G Ca 125ii Calibrators.
| Device ID | K142895 |
| 510k Number | K142895 |
| Device Name: | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Diana Dickson |
| Correspondent | Stacey A Dolan FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Product Code | LTK |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-03 |
| Decision Date | 2015-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850212007096 | K142895 | 000 |
| 04987270234273 | K142895 | 000 |
| 04987270231203 | K142895 | 000 |
| 04987270231197 | K142895 | 000 |
| 04987270231173 | K142895 | 000 |
| 04987270230688 | K142895 | 000 |
| 04987270234259 | K142895 | 000 |